Value of Continuous Liviu Klein MD, MS Monitoring of Associate - PDF document

12/18/15 ¡ Value of Continuous Liviu Klein MD, MS Monitoring of Associate Professor Pulmonary Artery Director, Mechanical Circulatory Support and Pressures in Heart Heart Failure Device Programs Failure Liviu.Klein@ucsf.edu Financial Relationship Disclosure Value of Continuous Monitoring of Pulmonary Artery Pressures in Heart Failure I will NOT discuss off label/ investigational use of products. The following financial relationships exist: Employer: University of California San Francisco. Current research support: CVRx, Department of Health and Human Services, National Institutes of Health, Novartis, St. Jude Medical, Sunshine Heart. Consultant: Boston Scientific, HeartWare, InfoBionic, Microsoft, Otsuka, St. Jude Medical, Thoratec. Honoraria: None. Stockholder: InfoBionic. 2 1 ¡

12/18/15 ¡ Heart Failure Hospitalizations Go AS et al. Circulation. 2014; 129: e28-e292. 3 High Post Discharge Mortality Solomon SD et al. Circulation. 2007; 116: 1482-1487. 4 2 ¡

12/18/15 ¡ Heart Failure ReHospitalizations Dharmarajan K et al. JAMA. 2013; 309: 355-363. Heart Failure ReHospitalizations Dharmarajan K et al. JAMA. 2013; 309: 355-363. 6 3 ¡

12/18/15 ¡ Heart Failure Signs/ Symptoms in Hospitalized Patients Admission Discharge Symptoms (%) Dyspnea on exertion 79 58 Dyspnea at rest 42 5 Orthopnea 50 12 PND 33 4 Fatigue 53 57 Signs (%) JVP > 8 cm 33 6 Rales 57 13 S3 gallop 20 6 Edema > 2+ 50 13 Gattis WA et al. J Am Coll Cardiol. 2004; 43: 1534-1540. Congestion Does not Translate in EARLY Signs/Symptoms • Among pts. with severe heart failure 1 – PCWP 33 ± 6 mmHg, CI 1.8 ± 0.5, LVEF 0.18 ± 0.06 – CXR: 27% no congestion, 41% minimal congestion • Among pts. with moderate heart failure 2 – PCWP 30 ± 9 mmHg, CI 2.1 ± 0.8, LVEF 0.18 ± 0.06 – No rales 84%, no edema 80%, no JVP 50%, no orthopnea 22% • Hemodynamic congestion may not be recognized clinically (doesn’t translate into symptoms/signs) until too late 1 Mahdyoon H et al. Am J Card. 1989; 63: 625-630. 2 Stevenson LW et al. JAMA. 1989; 261: 884-889. 4 ¡

12/18/15 ¡ Ability to Predict High PWP Sens. Spec. PPV NPV Dyspnea on exertion 66 52 45 27 Orthopnea 66 47 61 37 Edema 46 73 79 46 JVD 70 79 85 62 S3 73 42 66 44 CXR Cardiomegaly 97 10 61 --- Redistribution 60 68 75 52 Interstitial edema 60 73 78 53 Pleural effusion 43 79 76 47 Adapted from Chakko S. et al. Am J Med. 1991; 90: 353-358. Adapted from Butman SM. Et al. J Am Coll Cardiol. 1993; 22: 968-975. The Congestion Iceberg in Heart Failure Systemic congestion (Leg edema; JVD; Hepatomegaly) S ↑ RV + RA Pressure Y Abnormal lung mechanics Dyspnea Respiratory muscle ↑ PA Pressure M dysfunction Other factors Alveolar edema P ↑ Hydrostatic pressure ↑ Oncotic pressure T ↑ Permeability Redistribution in pulmonary vascular Lymphatic drainage capacity bed + interstitial edema Alveolar-capillary membrane O integrity Hemodynamic congestion (Increased PWP) M Neurohormonal activation => ↑ Blood volume S ↑ LV diastolic pressure Abnormal LV function (Sys and/or Dia) 5 ¡

12/18/15 ¡ Main Reasons for Broken Care Symptoms worsen Patient e Doesn’t recognize early r signs and symptoms a C Readmission Limited time Limited staff e MD Office Limited diagnostics v Limited monitoring i Limited intervention t c Limited patient education Hospitalization a e R Symptoms Pressure on length ED worsen of stay shortens time to test new Only alternative medication regimen ED MD with no patient relationship or educate Safest route medically and legally Standard of Care for Heart Failure in 2015 6 ¡

12/18/15 ¡ Weights and Heart Failure Hospitalizations Chaudhry SI et al. Circulation. 2007; 116: 1549-1554. 13 Weights and Non Heart Failure Hospitalizations Chaudhry SI et al. Circulation. 2007; 116: 1549-1554. 14 7 ¡

12/18/15 ¡ Lynga P et al. Eur J Heart Fail. 2012; 14: 438-444. 15 Weights and Heart Failure Hospitalizations Lynga P et al. Eur J Heart Fail. 2012; 14: 438-444. 16 8 ¡

12/18/15 ¡ Main Reasons for Broken Care e Symptoms worsen Patient r Doesn’t recognize early a signs and symptoms C Readmission Limited time e Limited staff v MD Office Limited diagnostics i Limited monitoring t c Limited intervention Limited patient education a Hospitalization o r P Symptoms Pressure on length ED worsen of stay shortens time to test new Only alternative medication regimen ED MD with no patient relationship or educate Safest route medically and legally Telemonitoring and HF Hospitalizations: TELE-HF Chaudhry SI et al. New Engl J Med. 2010; 363: 2301-2309. 18 9 ¡

12/18/15 ¡ Telemonitoring and Heart Failure : BEAT HF Ong M. AHA 2015. 19 Telemonitoring and Heart Failure : BEAT HF Ong M. AHA 2015. 20 10 ¡

12/18/15 ¡ Telemonitoring and Heart Failure : BEAT HF Ong M. AHA 2015. 21 Telemonitoring and Readmissions 11 ¡

12/18/15 ¡ c Main Reasons for Broken Care i m Symptoms worsen a Patient e n Doesn’t recognize early r y signs and symptoms a d Readmission C Limited time o Limited staff d m MD Office Limited diagnostics e Limited monitoring e t Limited intervention c H Limited patient education e Hospitalization r i D Symptoms Pressure on length ED worsen of stay shortens time to test new Only alternative medication regimen ED MD with no patient relationship or educate Safest route medically and legally Hemodynamics and Outcomes 60 60 Mortality Risk (%) Mortality Risk (%) 50 50 PCWP > 16 mm Hg CI > 2.6 L/min/m 2 40 40 P = 0.001 30 30 P = NS CI < 2.6 L/min/m 2 20 20 PCWP < 16 mm Hg 10 10 0 0 0 6 12 18 24 0 6 12 18 24 Time (months) Fonarow GC et al. Circulation 1994; 90: I-488 24 12 ¡

12/18/15 ¡ Congestion Precedes Most Heart Failure Hospitalizations Zile MR et al. Circulation. 2008; 118: 1433-1441. 25 Congestion Precedes Most Heart Failure Hospitalizations Zile MR et al. Circulation. 2008; 118: 1433-1441. 26 13 ¡

12/18/15 ¡ Heart Failure Pressure Sensor Sensor Nitinol Loops • No battery • 10 mm diameter • No leads • Maintain sensor position in vessel • Small size (3.5 x 2 x 15mm) Pressure sensitive capacitor Fused silica housing with silicone Inductor coil coating CardioMEMS™ HF System PA Sensor and Delivery System 4.5 cm 120 cm Patient Electronics PA Pressure Database System Physician Access Via Secure Website 14 ¡

12/18/15 ¡ No Impact on Blood Flow Flow around sensor Sensor in Distal PA 29 15 ¡

12/18/15 ¡ Accuracy of PA Measurements Abraham WT et al. Am Heart J. 2011; 161: 558-566. 16 ¡

12/18/15 ¡ CHAMPION Trial Abraham WT et al. Lancet. 2011; 377: 658-666. CHAMPION Trial Abraham WT et al. Lancet. 2011; 377: 658-666. 17 ¡

12/18/15 ¡ CHAMPION Trial Abraham WT et al. Lancet. 2011; 377: 658-666. CHAMPION Trial – Long Term Abraham WT et al. Lancet. 2015; in press. 18 ¡

12/18/15 ¡ CHAMPION Trial – Long Term Abraham WT et al. Lancet. 2015; in press. CHAMPION Trial – Long Term Abraham WT et al. Lancet. 2015; in press. 19 ¡

12/18/15 ¡ CHAMPION Trial: Symptoms vs. PAP Management Goldberg LR et al. HRS 2015 A Year Later @ UCSF 20 ¡

12/18/15 ¡ Congestion in Heart Failure • Congestion is the lead cause of HF hospitalizations • Congestion contributes to progression of HF • Patients leave hospital with congestion, resulting in high rehospitalization rate • Congestion is often subclinical and difficult to assess when present • Significant dissociation between hemodynamic and clinical congestion, even when hemodynamics are very abnormal • Need for better monitoring of degree and changes in congestion (more accurate and sensitive) Conclusions • Monitoring PAP/ PWP can provide early warning of condition worsening/ decompensation much better than body weight and before symptoms • Most changes occur over a few days - weeks • Having a treatment algorithm based on PAP/ PWP values is key to successful treatment and preventing heart failure readmissions • Always treat to max: drive pressures down to patient’s normal 21 ¡